Phase IV clinical studies provide pharmaceutical organizations with valuable insight into FDA-approved therapies. Trial design, methodology, and operational considerations are key to the success of these studies, but gathering pre-execution insight from KOLs can be challenging due to scheduling conflicts, geographic location, and other considerations. How can pharmaceutical teams efficiently gather the insight they need to ensure successful trial design?
A medical affairs team wanted to engage physician and nurse KOLs located all over the US to obtain insights and perspective on trial design. Specifically, the team wanted to assess the ability to successfully use a drug in low-acuity settings previously only prescribed in high-acuity settings. The team had a number of challenges to obtaining sufficient feedback from KOLs, including:
- Finding time for physicians and nurses in different time zones and with conflicting schedules to have a discussion
- Concern about hierarchy influence, in which nurses might be influenced by physicians’ opinions, or even refrain from contributing
- Adhering to critical deadlines to proceed with the trial
The medical affairs team used the Within3 virtual engagement platform to address each of its primary challenges. The platform’s over-time capabilities enabled doctors and nurses to participate in the meeting whenever it was convenient for them, from any connected device, during a week-long session. Physicians and nurses answered 14 questions in separate virtual rooms. To ensure every participant could answer questions freely without influence by other advisors, questions were private and only visible by moderators. In addition, the advisors’ identities were blinded.
Typically, planning and conducting a live meeting of this complexity would take up to three months. However, by working with the Within3 client success team to upload content and invite and train participants, the medical affairs team was able to plan and execute the virtual meeting in just a few weeks.
The team was able to plan and execute the advisory board meeting in weeks rather than months, enabling them to stay on track with critical deadlines. They gathered 36 pages of insight from the advisors, including several key takeaways that influenced the trial design. These findings were shared with medical affairs leadership, and included:
- The proposed BMI limit for study participants needed to be increased
- Suggested patient transfer protocol is too complex for nurses to follow in a busy clinical setting and needs to be shortened